WHO Dengue Light Case Report Form: Session 2
2025-12-01
Introduction
Principles, Objectives & Scope of Today’s Session
🙏 THANK YOU
- 15 experts completed the pre-meeting questionnaire
- 11 experts joined the first session (27 November)
- Thank you for your valuable contribution to the CRF refinement process
Guiding Principles
- Safe and inclusive space
- Shared vision & common goal
- Consensus-driven process
- Respectful, equal participation
- Short, focused interventions
Approach
We systematically reviewed all feedback from the 27 November expert session, including:
- Redefining and clarifying variables
- Reorganizing sections for coherence
- Proposals for additions or removals
- Consolidating outstanding questions
Objectives
- Review all CRF items, focusing on pending questions
- Clarify open issues raised by the expert group
- Confirm areas of emerging agreement
Outside Today’s Scope
- We will not make definitive decisions here and now:
- Final CRF structure & content will be shaped
- after WHO reviews all expert inputs
- and integrates consolidated recommendations.
Variables for Discussion 1.0
Demographics/Baseline
- Pregnancy: experts agreed to retain Pregnancy as a core variable.
Vitals
- defined by:
- Blood pressure
- Capillary refill
- Cold peripheries
- All listed vital signs were considered important for assessing shock, and a separate shock item was added.
- A clear and consistent definition will need to be included
- Level of consciousness: Discussion is needed on whether AVPU or GCS should be retained as the preferred assessment tool.
- Definition of shock: All listed vital signs were considered important for assessing shock, and a separate shock item was added.
- A clear and consistent definition will need to be included
- Level of consciousness: Discussion is needed on whether AVPU or GCS should be retained as the preferred assessment tool.
- Definition of obesity: Height and weight were not retained in this section. Obesity has been added under comorbidities, but its operational definition still needs to be discussed and agreed upon.
- Overall, all need to be included, and considered more important that symptoms
- Shock: Highly important. Needs to be carefully defined, needs further discussion
- Capillary refill ≥ 3 sec: Included in paediatric shock definition, and part of WHO guidelines
- Level of consciousness: discussion on whether to retain AVPU or GCS as the preferred assessment tool.
- Temperature: highlighted by one expert as an important parameter to include.
- Shock assessment: capillary refill time and SpO₂ identified as relevant markers of shock.
- Height/Weight: discussion on inclusion for BMI calculation and to define Obesity (see also comorbities).
Symptoms
❓ WHO Warning Signs
- Abdominal pain or tenderness
- Persistent vomiting
- Clinical fluid accumulation
- Mucosal bleed
- Lethargy, restlessness
- Liver enlargement >2 cm
- Laboratory: increase in HCT concurrent with rapid decrease in platelet count
- WHO warning signs: Should this be used as an umbrella category encompassing the symptoms and laboratory findings defined in the WHO classification?
- Considerations include feasibility, clarity, and whether this grouping sufficiently captures the clinical information needed.
- Bleeding: Added as a separate variable.
- Note that Severe Bleeding: Currently considered under complications and as part of the parent term Shock.
- Panel discussion may clarify whether it should remain a distinct variable.
- Note that Severe Bleeding: Currently considered under complications and as part of the parent term Shock.
- Signs of ascites and pleural effusion: considered important, with discussion on the best way to capture these variables.
- Fever: suggested for exclusion by some experts.Non-discrimatory, Also captured by temperature
- Seizures: suggested for exclusion by some experts due to difficulty/reliability of recollection.
- WHO warning signs: could serve as an umbrella term to include persistent vomiting and abdominal pain; importance of balancing feasibility, accuracy, and clinical relevance was emphasized.
- Bleeding: discussion on whether to include as a symptom.
Comorbidities
❓ Chronic kidney disease
❓ Chronic heart disease (e.g., heart failure, coronary artery disease)
❓ Chronic liver disease
❓ Immunosuppressive condition or Immunosuppressive medication
- Chronic liver disease, chronic cardiac disease, and chronic kidney disease:
- Should these conditions be considered mandatory variables to capture?
- Experts noted the challenges related to their definition, consistent classification, and reliable recollection by patients or caregivers.
- Should these conditions be considered mandatory variables to capture?
- Immunosuppressive condition or Immunosuppressive medication:
- Experts noted the challenges related to its strict definition.
- Obesity:
- Experts expressed the need to capture this variable.
- Requires clear and strict definition criteria.
- Experts expressed the need to capture this variable.
- Obesity: discussion on inclusion; also noted the need to retain height and weight for BMI calculation in vitals.
- Prematurity: suggested for consideration in pediatric patients, though not deemed critical by all experts.
- Hypertension (HTA): recommended to be added as a comorbidity and moved out of the complications section.
- Chronic disease: noted challenges in reliable recollection by participants.
- Cancer: considered for exclusion by some experts
Laboratory and Imagery
❓ DENV serotype
❓ Hematocrit
- Hematocrit and hemoglobin:
- Should hematocrit be used as the primary marker for assessing anemia, given its potential advantages over hemoglobin? - Clarification is needed on whether hematocrit should be considered as a standalone criterion.
- DENV serotype: While acknowledging that serotyping is not available in all settings, it remains a valuable variable when available and can be captured rapidly.
- The panel should consider whether its inclusion would meaningfully increase the burden on data collectors.
- DENV serotype: considered important, though acknowledged as not available in all settings.
- Hemoglobin: experts noted that hematocrit may be a better marker, being less affected by potential hemoconcentration.
- Creatinine: considered important for defining AKI.
- Availability of blood count results: suggested for exclusion by some experts.
Complications
- Respiratory Complications. Including but not limited to:
- Acute Respiratory Distress Syndrome (ARDS)
- Cardiac Complications. Including but not limited to:
- Cardiac arrest/ Cardiac arrhythmia / Shock
- Myocarditis / Pericarditis
- Liver Complications. Including but not limited to:
- Acute hepatitis
- Hepatic encephalopathy (any grade) / Severe liver disease (new onset)
- Renal Complications. Including but not limited to:
- Acute renal injury / Acute renal failure
- Urine flow rate
- Neurological Complications. Including but not limited to:
- Encephalitis / Meningitis
- Focal neurological signs
- Pleural effusion / Ascites
❓ Severe bleeding
- Severe Organ Impairment: Proposal to reclassify variables related to liver dysfunction, cardiac complications, and brain injury under the umbrella term Severe Organ Impairment.
- Discussion is needed to clarify the boundaries of this definition and which specific conditions or indicators should be included.
- Severe Bleeding: Also considered under the parent term Shock.
- Panel discussion needed on whether it should be retained as a separate variable.
- Severe Organ Impairment: suggested reclassification under the umbrella term Severe Organ Impairment for variables related to liver dysfunction, cardiac complications, and brain injury.
- Fluid overload: suggested reclassification under the umbrella term Fluid overload for variables such as pleural effusion and ascites.
- Seizure: suggested for exclusion by some experts.
Treatments
❓ Diuretics
❓ Highest level of care
❓ Renal replacement therapy (e.g., dialysis)
❓ NSAIDs
- Fluid drainage: Experts agreed to remove this variable as it is not routinely performed in practice.
- Discussion is needed on whether diuretics should be included instead.
- Antivirals: suggested for exclusion by some experts.
- Fluid drainage (Therapeutic ascitic/pleural tap included): There was discussion the need to keep as not done in every settings. Use of Diuretic was also mentioned.
- NSAIDs: In addition to NSAIDs, Paracetamol was mentioned as a possible cause of liver dysfunction
Variables for Discussion 2.0
Demographics/Baseline
Is the patient currently pregnant or was pregnant in the last 6 weeks?
- Pregnancy: experts agreed to retain Pregnancy as a core variable.
Vitals
AVPU Capillary refill ≥ 3 sec GCS SpO2 Temperature Height/Weight Respiratory rate Shock defined by: - Blood pressure
- Capillary refill
- Cold peripheries
- Definition of shock: All listed vital signs were considered important for assessing shock, and a separate shock item was added.
- A clear and consistent definition will need to be included
- Level of consciousness: Discussion is needed on whether AVPU or GCS should be retained as the preferred assessment tool.
- Definition of obesity: Height and weight were not retained in this section. Obesity has been added under comorbidities, but its operational definition still needs to be discussed and agreed upon.
- Overall, all need to be included, and considered more important that symptoms
- Shock: Highly important. Needs to be carefully defined, needs further discussion
- Capillary refill ≥ 3 sec: Included in paediatric shock definition, and part of WHO guidelines
- Level of consciousness: discussion on whether to retain AVPU or GCS as the preferred assessment tool.
- Temperature: highlighted by one expert as an important parameter to include.
- Shock assessment: capillary refill time and SpO₂ identified as relevant markers of shock.
- Height/Weight: discussion on inclusion for BMI calculation and to define Obesity (see also comorbities).
Symptoms
- WHO Warning Signs:
- Abdominal pain or tenderness
- Persistent vomiting
- Clinical fluid accumulation
- Mucosal bleed
- Lethargy, restlessness
- Liver enlargement >2 cm
- Laboratory: increase in HCT concurrent with rapid decrease in platelet count
Signs of ascites and pleural effusion Bleeding Confusion or agitation Fever Seizures
- WHO warning signs: Should this be used as an umbrella category encompassing the symptoms and laboratory findings defined in the WHO classification?
- Considerations include feasibility, clarity, and whether this grouping sufficiently captures the clinical information needed.
- Bleeding: Added as a separate variable.
- Note that Severe Bleeding: Currently considered under complications and as part of the parent term Shock.
- Panel discussion may clarify whether it should remain a distinct variable.
- Note that Severe Bleeding: Currently considered under complications and as part of the parent term Shock.
- Signs of ascites and pleural effusion: considered important, with discussion on the best way to capture these variables.
- Fever: suggested for exclusion by some experts.Non-discrimatory, Also captured by temperature
- Seizures: suggested for exclusion by some experts due to difficulty/reliability of recollection.
- WHO warning signs: could serve as an umbrella term to include persistent vomiting and abdominal pain; importance of balancing feasibility, accuracy, and clinical relevance was emphasized.
- Bleeding: discussion on whether to include as a symptom.
Comorbidities
Diabetes (type 1 or type 2) Obesity Hypertension (HTA) - ❓ Chronic heart disease (e.g., heart failure, coronary artery disease)
- ❓ Chronic kidney disease
- ❓ Chronic liver disease
- ❓ Immunosuppressive condition or Immunosuppressive medication
Cancer diagnosis Bleeding disorder or take anticoagulant/antiplatelet medication
- Chronic liver disease, chronic cardiac disease, and chronic kidney disease:
- Should these conditions be considered mandatory variables to capture?
- Experts noted the challenges related to their definition, consistent classification, and reliable recollection by patients or caregivers.
- Should these conditions be considered mandatory variables to capture?
- Immunosuppressive condition or Immunosuppressive medication:
- Experts noted the challenges related to its strict definition.
- Obesity:
- Experts expressed the need to capture this variable.
- Requires clear and strict definition criteria.
- Experts expressed the need to capture this variable.
- Obesity: discussion on inclusion; also noted the need to retain height and weight for BMI calculation in vitals.
- Prematurity: suggested for consideration in pediatric patients, though not deemed critical by all experts.
- Hypertension (HTA): recommended to be added as a comorbidity and moved out of the complications section.
- Chronic disease: noted challenges in reliable recollection by participants.
- Cancer: considered for exclusion by some experts
Laboratory and Imagery
- ❓ DENV serotype
- ❓ Hematocrit
Creatinine Blood count results available Hemoglobin
- Hematocrit and hemoglobin:
- Should hematocrit be used as the primary marker for assessing anemia, given its potential advantages over hemoglobin? - Clarification is needed on whether hematocrit should be considered as a standalone criterion.
- DENV serotype: While acknowledging that serotyping is not available in all settings, it remains a valuable variable when available and can be captured rapidly.
- The panel should consider whether its inclusion would meaningfully increase the burden on data collectors.
- DENV serotype: considered important, though acknowledged as not available in all settings.
- Hemoglobin: experts noted that hematocrit may be a better marker, being less affected by potential hemoconcentration.
- Creatinine: considered important for defining AKI.
- Availability of blood count results: suggested for exclusion by some experts.
Complications
Severe Organ Impairment - Respiratory Complications. Including but not limited to:
- Acute Respiratory Distress Syndrome (ARDS)
- Cardiac Complications. Including but not limited to:
- Cardiac arrest/ Cardiac arrhythmia / Shock
- Myocarditis / Pericarditis
- Liver Complications. Including but not limited to:
- Acute hepatitis
- Hepatic encephalopathy (any grade) / Severe liver disease (new onset)
- Renal Complications. Including but not limited to:
- Acute renal injury / Acute renal failure
- Urine flow rate
- Neurological Complications. Including but not limited to:
- Encephalitis / Meningitis
- Focal neurological signs
- Respiratory Complications. Including but not limited to:
Fluid Overload - Pleural effusion / Ascites
- ❓ Severe bleeding
Hypertension Seizure Sepsis
- Severe Organ Impairment: Proposal to reclassify variables related to liver dysfunction, cardiac complications, and brain injury under the umbrella term Severe Organ Impairment.
- Discussion is needed to clarify the boundaries of this definition and which specific conditions or indicators should be included.
- Severe Bleeding: Also considered under the parent term Shock.
- Panel discussion needed on whether it should be retained as a separate variable.
- Severe Organ Impairment: suggested reclassification under the umbrella term Severe Organ Impairment for variables related to liver dysfunction, cardiac complications, and brain injury.
- Fluid overload: suggested reclassification under the umbrella term Fluid overload for variables such as pleural effusion and ascites.
- Seizure: suggested for exclusion by some experts.
Treatments
Blood transfusion Platelets - ❓ Diuretics
Antivirals Fluid drainage (Therapeutic ascitic/pleural tap included) - ❓ Highest level of care
- ❓ Renal replacement therapy (e.g., dialysis)
- ❓ NSAIDs
- Fluid drainage: Experts agreed to remove this variable as it is not routinely performed in practice.
- Discussion is needed on whether diuretics should be included instead.
- Antivirals: suggested for exclusion by some experts.
- Fluid drainage (Therapeutic ascitic/pleural tap included): There was discussion the need to keep as not done in every settings. Use of Diuretic was also mentioned.
- NSAIDs: In addition to NSAIDs, Paracetamol was mentioned as a possible cause of liver dysfunction
Thank you
Dengue - Light CRF 2025